Inflammatory Response in Laparoscopic and Open Colectomy

Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery

This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Laparoscopic colectomy; Procedure: Open colectomy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Ioannina, Greece, 45001
    • G Hatzikosta General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• colorectal cancer

Exclusion Criteria:

• metastases
• stage 4 colorectal cancer
• recurrent disease
• chronic diseases
• obvious inflammatory condition

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic Surgery group; Group of patients that are operated with laparoscopic approach	Procedure: Laparoscopic colectomy; Laparoscopic colectomy. Epidural anaesthesia used
Active Comparator: Open surgery Group; Group of patients operated with open approach	Procedure: Open colectomy; Open colectomy. Epidural anaesthesia used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer	preoperative, intraoperative, 6h postop, 24h postop

Collaborators and Investigators

• Sponsor: G. Hatzikosta General Hospital
• Collaborators: University of Ioannina

Publications and helpful links

General Publications

• Tsimogiannis KE, Tellis CC, Tselepis AD, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Toll-like receptors in the inflammatory response during open and laparoscopic colectomy for colorectal cancer. Surg Endosc. 2012 Feb;26(2):330-6. doi: 10.1007/s00464-011-1871-2. Epub 2011 Sep 5.
• Tsimogiannis KE, Telis K, Tselepis A, Pappas-Gogos GK, Tsimoyiannis EC, Basdanis G. Alpha-defensin expression of inflammatory response in open and laparoscopic colectomy for colorectal cancer. World J Surg. 2011 Aug;35(8):1911-7. doi: 10.1007/s00268-011-1140-5.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 20, 2009
• First Posted (Estimate): July 21, 2009

Study Record Updates

• Last Update Posted (Estimate): July 21, 2009
• Last Update Submitted That Met QC Criteria: July 20, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: CRP; Inflammatory Cytokines; a-defensins; TLRs; No metastases; No other obvious inflammation; No chronic diseases
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: GH-1948-04; GHDS-12345-4